FDA WARNING_LETTER - McNeil Consumer and Specialty Pharmaceuticals - January 08, 2010

This FDA Warning Letter, dated [Date of Letter], addresses McNeil Consumer Healthcare's pharmaceutical manufacturing facility in Las Piedras, Puerto Rico, following an inspection concluded on January 8, 2010. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 C.F.R. Parts 210 and 211), rendering drug products adulterated under Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Failure to thoroughly investigate unexplained discrepancies (21 C.F.R. § 211.192):** The firm failed to adequately investigate "uncharacteristic odor" complaints, linked to 2,4,6 Tribromoanisole (TBA) contamination from TBP-treated wooden pallets. Investigations were delayed, prematurely terminated, and not extended to other potentially affected batches or products despite recurring complaints since 2008, leading to multiple recalls. 2. **Quality Control Unit deficiencies (21 C.F.R. § 211.192, 211.198):** The Quality Control Unit failed to ensure timely and thorough investigations, prolonging problem identification and consumer exposure to substandard drugs. 3. **Failure to submit NDA Field Alert Reports (FARs) (21 C.F.R